Senior Quality Analyst (Multiple positions)

AbbVie - Barceloneta, PR

Full-time - Mid Level

Barceloneta, PR

Chemical Manufacturing

About the position

Responsible for implementing and maintaining the effectiveness of the Quality System. Support manufacturing operations in the resolution of events, impact assessment and documentation discrepancies. Provide guidance for product/process impact analysis, perform holistic evaluation of events, review and approve investigations and risk based evaluations in support to routine operations and product disposition.

Responsibilities

• Investigate activities when an exception event occurs in the manufacturing, incoming laboratory, Quality Control laboratory, validation, microbiology, stability or complaints area.
• Responsible for consistent and thorough exception events investigation, documentation and timely resolution of exception documents based on CAPA requirements.
• Ensures investigations of plant events are evaluated in a timely manner; completed thoroughly and documented accurately in the plant CAPA system.
• Support routine operations to ensure that all quality goals are met, and all practices and procedures comply with AbbVie policies and applicable regulations for the Quality areas under responsibility.
• Serve as backup for the QA Manager leading the team and providing support to quality initiatives.
• Performs product impact analyses for plant events and places product on QA hold where appropriate.
• Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approves standard operating procedures; change management and risk management documents.
• Ensures all documents are in compliance with Abbvie global procedures and regulatory requirements.
• Approves calibration requests, calibration out of tolerance and preventive maintenance records.
• Demonstrates accountability and responsibility of EHS performance and compliance.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Oversees manufacturing operations to ensure practices are in alignment with approved procedures.
• Provide support to the Compliance team during internal and external audits as required.
• Provide guidance for new product introduction activities.
• Develop risk assessments to support manufacturing activities for new products and ensure material control until regulatory approval.
• Conform to EHS management system requirements and compliance obligations, promote continuous improvement, and consider EHS aspects during the design and change process.

Requirements

• Bachelors degree in Biotechnology, Biology, Chemistry or Engineering.
• Masters Degree in Science preferred.
• Minimum 4-5 years of experience in Pharmaceutical/Biotechnology industry in a similar position.
• Knowledge of quality / compliance /Investigations /Risk management as well as regulations and standards affecting biological products.
• Excellent written and spoken communication skills in English and Spanish.
• Knowledge of GMP, safety regulations.
• Quality/compliance management skills.
• Fast paced and adaptable to continuously changing environment.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Participation in short-term incentive programs